Americans count on the U.S. Food and Drug Administration (FDA) to regulate food and pharmaceutical items so that only the safest, most effective products hit the market. That’s definitely not the case, as these disturbing facts show. If you’re interested in pursuing a career in the medical field or just want to learn more about the processes of drug and food approval, consider these news stories and scandals that are inspiring FDA reform today.
1. They keep important drug information off the label: Two drug safety experts called out the FDA in the fall of 2009 for leaving off important drug information when listing ingredients on labels. Even doctors were left in the dark about certain drug information, and in the case of the osteoporosis drug, Zometa, a slightly higher dose could increase the risk of death in cancer patients.
2. Their tomato mistake ruined the industry: During one of the many salmonella outbreaks in the last few years, the FDA pointed to tomatoes as being the carrying culprit. People all over the country stopped eating tomatoes, a major ingredient in all types of foods made at home and in restaurants. The slow-down of the industry was a huge hit to farmers, and Florida lost most of its harvest because of the FDA’s cautioning. Turns out tomatoes had nothing to do with the outbreak whatsoever.
3. Budget cuts might be coming: Earlier this year, Congress looked ready to cut funding to the FDA as with many other government agencies. The FDA is worried about handling the fallout from Japanese radiation, however, possibly swaying President Obama to override the cuts and in fact give more money to the FDA for 2012.
4. The FDA approved canola oil: There’s a bit of debate among health experts and natural foodies about the safety of canola oil, which is no longer extracted from the somewhat toxic plant, rapeseed. Mayo Clinic blogger Katherine Zeratsky, R.D., L.D., points out that “canola oil is generally recognized as safe by the Food and Drug Administration,” which isn’t a very strong stance one way or the other, and it has actually been banned in Europe.
5. They failed to comment on a test subject’s suicide: A 19-year-old college student who was working as a test subject for the FDA as it researched a new antidepressant hanged herself in the lab of an Indianapolis-area drug company. Because the drug manufacturer hadn’t publicized any negative side effects about their product, the FDA was expected to share its findings and continue with research to attempt to find a reason for the suicide. They didn’t. Instead, the FDA said that if they released information about how the suicide and drug’s side effects were related, they would be releasing trade secrets, possibly compromising the drug company’s recipe and overall business.
6. The FDA tends to “sit on” questionable data: In a 2009 New York Times article, it was revealed that the FDA has a nasty habit — it “often sits on data that raise questions about a drug’s safety or therapeutic value.” In other words, FDA agents keep quiet when they learn about adverse side effects, including shocking symptoms like increased heart attack risks in one painkiller and an increase in children’s suicidal thoughts and behaviors in antidepressants. Their obsession with keeping trade secrets safe inspired a call for more transparency in the process of drug approval.
7. They were partly behind the Vioxx deaths: Along with drug company Merck, the FDA was blamed for promoting and refusing to recall the drug Vioxx, which “caused an untold number of fatalities among the American population,” according to NaturalNews.com. Apparently, the FDA was pressed to run additional clinical trials after Vioxx caused heart attacks, but the FDA approved the drug anyway, without extra research or recalls.
8. Just because a drug is approved, doesn’t mean the FDA believes it works well: The main rule of thumb for drug approval is that if its benefits outweigh its side effects, it gets the go-ahead to hit the market. But while many Americans think that FDA-approved medicine means the drug is high quality, it may not be.
9. FDA leaders have chosen to side with drug companies, and ignore science: Two years ago, a group of FDA scientists wrote a letter to President Obama asking for wholesale change of the organization, as they believed leaders were corrupt and consistently ignoring their research, and instead choosing to promote drug companies. At first, some believed the letter was a fake, but when it was validated, a closer look of the letter revealed that the scientists also accused the FDA of actually breaking their own laws, “altering scientific findings,” removing Black Box warnings, made false statements in FDA documents, and the approval of a mammogram device after FDA experts voted unanimously against it.
10. They re-approved a drug that killed 80,000 people: Many health and patient advocates felt that the diabetes drug Avandia should be taken off the market after it was suspected of killing around 80,000 people, but after a special meeting was called, the FDA disagreed. Although the FDA proved through a vote that they believed the drug was dangerous, they decided stronger warning labels would be a sufficient solution.
11. Most Americans don’t approve of the FDA’s alleged neutrality: Four out of five Americans believe that the FDA is too heavily influenced by drug companies, and 96% of Americans want the government to put warning labels on drugs with known safety concerns.
12. It’s all relative: In a report by NaturalNews.com, the FDA’s twisted logic for drug approval was unwound. Their decisions are based on relative comparisons — not on drug safety but on drug deadliness. If a drug is no more deadly than any other comparable drug on the market, it can be approved.
13. Stock scandal: A FDA chemist was charged with insider trading, stockpiling — along with his son — $3.6 million. He used inside information about drug approvals to make calculated trades.
14. “Extraordinarily complex” data is an excuse for making the wrong decisions: When called out on the Avandia scandal, FDA officers blamed the drug company Glaxo for throwing “extraordinarily complex” data at them, apparently thinking that was a valid excuse for making a bad decision endangering tens of thousands of lives.
15. They were reluctant to pursue criminal prosecutions: Last spring, the FDA began stepping up its criminal prosecutions of offending drug and food company executives after it was pressured by Congress to do so. Critics of the FDA had noticed that the agency was being too lax with its investigations and had “fallen short” in terms of developing performance standards in its criminal unit.